Longitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP)

Status Recruiting

Clinical Trial Summary

Immune thrombocytopenic purpura (ITP) is a kind of rare childhood disease that involve autoimmune destruction of platelets.The current Pediatric ITP cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in pediatric ITP. The purpose of this study is to analyze the clinical characteristics of Pediatric ITP, the treatment methods, prognosis and prognostic model of these patients in China.

Clinical Trial Description

Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a considerable number of patients need drug maintenance treatment, which seriously affects the quality of life of patients and increases the economic burden of patients. Longitudinal Cohort allows to describe the long-term clinical characteristics of pediatric ITP patients, to study the benefit-risk balance of treatments, including the growing development of targeted therapies and to analyze the prognostic factors and attempts to establish prognostic models. The study will include pediatric patients diagnosed with primary immune thrombocytopenia in the investigating hospitals, and collect basic information, diagnostic and treatment information from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information. ;

Study Design

Related Conditions & MeSH terms

Primary Immune Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Thrombocytopenia

Clinical Trial Details

NCT number	NCT06107582
Study type	Observational
Source	Institute of Hematology & Blood Diseases Hospital, China
Contact	Ting Sun, MD
Phone	02223909009
Email	sunting@ihcams.ac.cn
Status	Recruiting
Phase
Start date	November 1, 2023
Completion date	December 2036

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06466824` - Observational Study on the Outcome of Patients With ITP Who Underwent Splenectomy After 2010
Completed	`NCT05621330` - Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia	Phase 3
Active, not recruiting	`NCT04278924` - A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia	Phase 2
Recruiting	`NCT06148389` - The Safety and Tolerability of STSA-1301 Subcutaneous Injection in Healthy Subjects	Phase 1
Active, not recruiting	`NCT04812925` - A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia	Phase 3
Recruiting	`NCT05371743` - Plasma microRNA Levels and Some Cytokines Expression in Patients With ITP Primary Immune Thrombocytopenic Purpura (ITP)
Not yet recruiting	`NCT05333861` - An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA
Not yet recruiting	`NCT05311930` - Efficacy and Safety of TPO Receptor Agonists in the Treatment of Elderly ITP Patients	Phase 4
Completed	`NCT03102593` - A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP	Phase 2
Completed	`NCT06071520` - Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
Recruiting	`NCT04949009` - Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP)
Terminated	`NCT04224688` - A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)	Phase 3
Active, not recruiting	`NCT04225156` - A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).	Phase 3
Completed	`NCT05551624` - Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine	Early Phase 1
Recruiting	`NCT05422365` - Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults	Phase 3
Terminated	`NCT03275740` - A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347	Phase 1
Terminated	`NCT04596995` - A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)	Phase 3
Terminated	`NCT04200456` - A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)	Phase 3
Recruiting	`NCT05653219` - A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids	Phase 3
Completed	`NCT01727232` - Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia	N/A